03.28.11
The FDA has tipped its hat to the most recent product offering from TranS1 Inc.
The company, which designs minimally invasive device approaches to lumbar spine surgery, received 510(k) clearance for its AxiaLIF(R) 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion.
The AxiaLIF 1L+ system is the next generation of the original AxiaLIF 1L system, which first was launched in 2005, and, according to the company, has a clinical history of more than 10,000 implants. TranS1 will begin with a limited market release immediately and anticipates full commercial release in the second half of the year.
"Our new AxiaLIF 1L+ system further demonstrates TranS1's commitment tocontinuously advance our proprietary AxiaLIF core technology. The 1L+ system builds upon our successful 2L+ system launched last year," said Ken Reali, TranS1's president and CEO. "The modular approach of the 1L+, coupled with the tapered tip design, allows for more precise distraction capabilities and improvement in pull out strength. Further, through our minimally invasive pre-sacral access, the 1L+ implant provides a biomechanically stable implant at the base of the spine."
James Billys, M.D., from the Florida Orthopedic Institute called the new product "exciting."
"The 1L+ represents a real advancement in the AxiaLIF technology that will allow me to manually distract the L5-S1 disc space providing even greater control of the procedure and ultimately a strong fusion outcome," Billys said.
Based in Wilmington, N.C., TranS1 is develops products to treat degenerative conditions of the spine affecting the lower lumbar region. TranS1 currently markets the AxiaLIF family of products for single and multilevel lumbar fusion and the Vectre and Avatar posterior fixation
systems.
The company was founded in May 2000.
The company, which designs minimally invasive device approaches to lumbar spine surgery, received 510(k) clearance for its AxiaLIF(R) 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion.
The AxiaLIF 1L+ system is the next generation of the original AxiaLIF 1L system, which first was launched in 2005, and, according to the company, has a clinical history of more than 10,000 implants. TranS1 will begin with a limited market release immediately and anticipates full commercial release in the second half of the year.
"Our new AxiaLIF 1L+ system further demonstrates TranS1's commitment tocontinuously advance our proprietary AxiaLIF core technology. The 1L+ system builds upon our successful 2L+ system launched last year," said Ken Reali, TranS1's president and CEO. "The modular approach of the 1L+, coupled with the tapered tip design, allows for more precise distraction capabilities and improvement in pull out strength. Further, through our minimally invasive pre-sacral access, the 1L+ implant provides a biomechanically stable implant at the base of the spine."
James Billys, M.D., from the Florida Orthopedic Institute called the new product "exciting."
"The 1L+ represents a real advancement in the AxiaLIF technology that will allow me to manually distract the L5-S1 disc space providing even greater control of the procedure and ultimately a strong fusion outcome," Billys said.
Based in Wilmington, N.C., TranS1 is develops products to treat degenerative conditions of the spine affecting the lower lumbar region. TranS1 currently markets the AxiaLIF family of products for single and multilevel lumbar fusion and the Vectre and Avatar posterior fixation
systems.
The company was founded in May 2000.